Accuracy of CRISPR/Cas-based nucleic acid detection for HIV-1: a systematic review and meta-analysis
Abstract
Background and aimsHIV continues to pose a substantial worldwide public health burden, and achieving the UNAIDS 95–95-95 goals depends on diagnostics that are reliable, rapid, and inexpensive. Because of its exceptional specificity and adaptable design, the CRISPR-Cas platform has emerged as an attractive option for nucleic acid detection. In this systematic review and meta-analysis, we assessed the diagnostic accuracy of CRISPR-Cas-based assays for HIV-1, aiming to clarify their suitability for point-of-care testing and resource-limited settings.MethodsWeb of Science, PubMed, and CNKI were searched through August 12, 2026. We included original studies that applied CRISPR-Cas assays to detect HIV-1 nucleic acids and reported sufficient data to construct 2 × 2 tables (TP, FP, FN, TN), with RT-qPCR for HIV-1 RNA or qPCR for HIV-1 DNA serving as the reference standard. Pooled sensitivity, specificity, and SROC curves were generated using a bivariate random-effects model. Subgroup analyses and meta-regression were performed to investigate heterogeneity.ResultsNine studies met the inclusion criteria. The pooled sensitivity was 0.96 (95% CI 0.90–0.98) and the pooled specificity was 0.98 (95% CI 0.93–1.00), with an AUC of 0.99. The I2 statistic revealed low heterogeneity (11.82% for sensitivity and 8.91% for specificity). Publication bias was not statistically significant (Deeks’ test, p = 0.925). When stratified by Cas protein, Cas12a yielded a sensitivity of 0.97 and a specificity of 0.98, while Cas13a showed a sensitivity of 0.93 and a specificity of 0.99. However, each subgroup comprised only four to five studies, and between-subgroup differences were not formally examined. The use of fluorescence readout did not significantly influence accuracy (p > 0.05). Studies using RPA/RAA amplification achieved accuracy comparable to the overall pooled estimates.ConclusionIn selected studies, CRISPR-Cas-based assays showed high sensitivity and specificity for HIV-1, but clinical equivalence to qPCR remains unproven. When combined with RPA/RAA isothermal amplification, it holds promise as a rapid, accurate point-of-care testing (POCT) tool. Nevertheless, limited studies and methodological concerns highlight the need for further multicenter validation and real-world implementation data.Systematic review registrationThis systematic review and meta-analysis was registered with the Open Science Framework (OSF). The registration DOI is 10.17605/OSF.IO/AUTV8.
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BibTeX
@article{hu2026accuracy,
title = {{Accuracy of CRISPR/Cas-based nucleic acid detection for HIV-1: a systematic review and meta-analysis}},
author = {Hongyang Hu and Xiang Zhang and Xiaoxue Wu and Xiangying Zhang},
journal = {Frontiers in Microbiology},
year = {2026},
month = nov,
doi = {10.3389/fmicb.2026.2018751},
url = {https://www.frontiersin.org/articles/10.3389/fmicb.2026.2018751},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Accuracy of CRISPR/Cas-based nucleic acid detection for HIV-1: a systematic review and meta-analysis
AU - Hongyang Hu
AU - Xiang Zhang
AU - Xiaoxue Wu
AU - Xiangying Zhang
PY - 2026
DA - 2026/11/09
JO - Frontiers in Microbiology
DO - 10.3389/fmicb.2026.2018751
UR - https://www.frontiersin.org/articles/10.3389/fmicb.2026.2018751
AB - Background and aimsHIV continues to pose a substantial worldwide public health burden, and achieving the UNAIDS 95–95-95 goals depends on diagnostics that are reliable, rapid, and inexpensive. Because of its exceptional specificity and adaptable design, the CRISPR-Cas platform has emerged as an attractive option for nucleic acid detection. In this systematic review and meta-analysis, we assessed the diagnostic accuracy of CRISPR-Cas-based assays for HIV-1, aiming to clarify their suitability for point-of-care testing and resource-limited settings.MethodsWeb of Science, PubMed, and CNKI were searched through August 12, 2026. We included original studies that applied CRISPR-Cas assays to detect HIV-1 nucleic acids and reported sufficient data to construct 2 × 2 tables (TP, FP, FN, TN), with RT-qPCR for HIV-1 RNA or qPCR for HIV-1 DNA serving as the reference standard. Pooled sensitivity, specificity, and SROC curves were generated using a bivariate random-effects model. Subgroup analyses and meta-regression were performed to investigate heterogeneity.ResultsNine studies met the inclusion criteria. The pooled sensitivity was 0.96 (95% CI 0.90–0.98) and the pooled specificity was 0.98 (95% CI 0.93–1.00), with an AUC of 0.99. The I2 statistic revealed low heterogeneity (11.82% for sensitivity and 8.91% for specificity). Publication bias was not statistically significant (Deeks’ test, p = 0.925). When stratified by Cas protein, Cas12a yielded a sensitivity of 0.97 and a specificity of 0.98, while Cas13a showed a sensitivity of 0.93 and a specificity of 0.99. However, each subgroup comprised only four to five studies, and between-subgroup differences were not formally examined. The use of fluorescence readout did not significantly influence accuracy (p > 0.05). Studies using RPA/RAA amplification achieved accuracy comparable to the overall pooled estimates.ConclusionIn selected studies, CRISPR-Cas-based assays showed high sensitivity and specificity for HIV-1, but clinical equivalence to qPCR remains unproven. When combined with RPA/RAA isothermal amplification, it holds promise as a rapid, accurate point-of-care testing (POCT) tool. Nevertheless, limited studies and methodological concerns highlight the need for further multicenter validation and real-world implementation data.Systematic review registrationThis systematic review and meta-analysis was registered with the Open Science Framework (OSF). The registration DOI is 10.17605/OSF.IO/AUTV8.
SN - 1664-302X
ER -